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NCT05600894 · ClinicalTrials.gov registry record · Phase 2
Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm
A Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
- 20
- Study locations
NCT05600894: Active Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by National Cancer Institute (NCI).
NCT05600894 is a Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 132 participants, below the 206-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (36% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05600894, a Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial tests whether decitabine and cedazuridine (ASTX727) in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) with excess blasts. Blasts are immature blood cells. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. The combination of ASTX727 and venetoclax may be more effective in reducing the cancer signs and symptoms in patients with CMML, or MDS/MPN with excess blasts.
Primary Outcome
The complete remission rate will be compared between two arms using Fisher's exact test. Logistical regression will be used to estimate the effect of combination treatment on complete remission adjusting for covariates of interest.
Conditions Studied
Interventions
- DRUG Venetoclax
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- DRUG Decitabine and Cedazuridine
Study Locations (20)
California
- UC Irvine Health Cancer Center-Newport - Costa Mesa
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UCI Health Laguna Hills - Laguna Hills
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
Illinois
- Northwestern University - Chicago
- University of Chicago Comprehensive Cancer Center - Chicago
- UC Comprehensive Cancer Center at Silver Cross - New Lenox
- University of Chicago Medicine-Orland Park - Orland Park
Kansas
- University of Kansas Cancer Center - Kansas City
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
Connecticut
- Yale University - New Haven
Florida
- Mayo Clinic in Florida - Jacksonville
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2023-06-27 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 2 |
What the registry record for NCT05600894 still lists
NCT05600894 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 206-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (36% lower).
The record links to 5 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.
NCT05600894 names 20 study sites across 9 states, led by California, Illinois, Kansas.
Frequently Asked Questions
What is clinical trial NCT05600894 about?
NCT05600894 is a clinical study titled "Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm". This phase II trial tests whether decitabine and cedazuridine (ASTX727) in combination with venetoclax work better than ASTX727 alone at decreasing symptoms of bone marrow cancer in patients with chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) w...
What is the current status of trial NCT05600894?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2023-06-27. Estimated completion is 2026-08-31.
What conditions does trial NCT05600894 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Myeloproliferative Neoplasm, Myelodysplastic/Myeloproliferative Neoplasm, Myelodysplastic Syndrome With Excess Blasts.
What interventions are being tested in trial NCT05600894?
The interventions under investigation include: Venetoclax (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Decitabine and Cedazuridine (DRUG).
Who is sponsoring clinical trial NCT05600894?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05600894 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05600894's enrollment target sits among peer trials
132 27th of 134 higher than 108 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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